HLB cleared one hurdle with the FDA last year—but it was Hengrui’s factory in China that tripped the filing up again.
Just 10 hours after the agency issued a second complete response letter (CRL) rejecting CAM-RIVO—HLB’s liver cancer combo of PD-1 inhibitor camrelizumab and VEGFR inhibitor rivoceranib—over unresolved manufacturing lapses at the Suzhou site, the Korean drugmaker came out swinging.
In a hastily arranged 9 a.m. press conference Friday, executives downplayed the setback as a fixable bump in the road. “We know our drug works,” Chairman Jin Yang-gon said, emphasizing that efficacy wasn’t in question. “We just have to get the paperwork and procedures right.”
From left, Han Yong-hae, CTO of HLB; Jin Yang-gon, Chairman of HLB; and Chong Sae-ho, CEO of Elevar Therapeutics, during an online press conference Friday morning to address the FDA’s second rejection of CAM-RIVO over manufacturing issues at Hengrui’s plant.
From left, Han Yong-hae, CTO of HLB; Jin Yang-gon, Chairman of HLB; and Chong Sae-ho, CEO of Elevar Therapeutics, during an online press conference Friday morning to address the FDA’s second rejection of CAM-RIVO over manufacturing issues at Hengrui’s plant.
CAM-RIVO faced another setback over manufacturing issues—specifically at a plant in Suzhou, China, run by Suzhou Suncadia Biopharmaceuticals, a wholly owned subsidiary of Hengrui, HLB’s Chinese partner. The FDA flagged lapses in sterilization, quality control, and electronic systems.
Compared to the 10-observation Form 483 issued in December 2023—which tanked the company’s first submission in May last year—the latest report contains just three. That alone, said CTO Han Yong-hae, shows how far they’ve come.
The three cited issues included lax microbiological contamination controls, inconsistent visual inspection protocols, and automation systems that were either incomplete or poorly validated. Of those, Han pointed to sterilization lapses as “likely the most serious,” but insisted the issues were procedural, not scientific. “These aren’t fundamental problems with the drug,” he said. “They’re fixable.”
Still, the miss has stung—and left HLB scrambling to reset expectations. The company is aiming to refile by May and says an FDA decision could land as early as July, assuming the agency grants a Class 1 review. That would match the company's timeline last year when it submitted a new application just four months after receiving its first CRL in May.
Jin said the company tapped a former head of the FDA’s CMC division to support its latest resubmission. "We don't think this will escalate to Class 2," he said. "The timeline depends on whether we're asked to go through another inspection."
HLB expects Hengrui to receive a post-action letter from the FDA within two to three weeks. That should pinpoint the agency’s lingering concerns—and allow the company to respond within a month.
Jin also dismissed any suggestions that CAM-RIVO's struggles reflect broader U.S.-China regulatory friction. "There’s a narrative that Chinese drugs are being singled out," he said. "But dozens of Chinese biologics have been approved in the past year. This isn’t about politics."
He pointed to recent FDA approvals from BeiGene and Junshi as evidence. Relocating manufacturing out of China, he added, would only delay things further.
"Building a new supply chain would set us back years," he said. "Fixing what we have is the fastest path forward."
The company still plans to pursue European approval for CAM-RIVO. While executives initially said during the conference that they were targeting July, an HLB spokesperson later clarified via Telegram that the EMA filing is more likely in September.
HLB now faces added pressure from Bristol Myers Squibb, whose Opdivo-Yervoy combo—CAM-RIVO’s closest rival in liver cancer—is slated for an FDA decision next month. CAM-RIVO has shown a slightly stronger hazard ratio and comparable survival benefit, but missing the timing window could cede valuable ground.
Even so, Jin wasn’t rattled. "We’re confident in our clinical data," he said. "If we make our case at the ground level, we can still win share."
For now, the focus remains squarely on liver cancer. Other indications, like adenoid cystic carcinoma and bile duct cancer, remain in play but aren’t top priority. He also downplayed any pivot to rivoceranib monotherapy. It works, he said, but with the patent set to expire in 2034, "the economics just don’t add up."
Two CRLs in under a year is a bruising record. But HLB is betting that the third time’s the charm—and that FDA patience hasn’t worn thin just yet.
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Kim Ji-hye jkim404@docdocdoc.co.kr
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